GxP-Agent: Process-DAG Topology for Reliable Clinical Trial Programming with LLM Agents

arXiv:2608.16890v1 Announce Type: new Abstract: Clinical trial programming -- transforming study protocols into analysis-ready datasets under CDISC standards -- is a bottleneck in regulatory submissions, yet LLM-based code generation fails catastrophically on this task: across 11 single-shot attempts with five frontier models, none produces a valid subject-level analysis dataset. We introduce GxP-Agent, a multi-agent system that encodes regulatory process ordering as a directed acyclic graph (DAG), decomposing monolithic dataset generation into 15 domain-specific nodes executed by worker agents with pharmaverse skill context, validation gates, and conditional retry. On CDISC-Bench, a new exe